Return of Results in Participant-Driven Research: Learning from Transformative Research Models.

Participant-driven research (PDR) is a burgeoning domain of research innovation, often facilitated by mobile technologies (mHealth). Return of results and data are common hallmarks, grounded in transparency and data democracy. PDR has much to teach traditional research about these practices and successful engagement. Recommendations calling for new state laws governing research with mHealth modalities common in PDR and federal creation of review mechanisms, threaten to stifle valuable participant-driven innovation, including in return of results.

Ultrasound in rural India: a failure of the best intentions.

The Pre-Conception and Pre-Natal Diagnostic Techniques Act was written to prevent societally unacceptable harms including intentional sex selection. The pragmatism required to enforce this law has profound effects on the ability of rural Indians to access diagnostic ultrasonography. In so doing, it may have inadvertently placed a heavier burden on the poorest and worsened health inequity in India, creating serious ethical and justice concerns. It is time to re-examine and update the law such that diagnostic ultrasonography is widely available in even the most peripheral primary health and community health centres. Shorter, more accessible ultrasonography training courses should be offered; collaboration between radiologists and rural practitioners and facilities should be encouraged. Finally, modern ultrasound machines can carefully record all images via a "silent observer" modality. With some modifications to previously used silent observer modalities, this technology allows both greater access and better policing of potential misuse of ultrasound technology.

Where is the human in the data? A guide to ethical data use.

Being asked to write about the ethics of big data is a bit like being asked to write about the ethics of life. Big data is now integral to so many aspects of our daily lives-communication, social interaction, medicine, access to government services, shopping, and navigation. Given this diversity, there is no one-size-fits-all framework for how to ethically manage your data. With that in mind, I present seven ethical values for responsible data use.

Ethical Challenges Raised by OpenNotes for Pediatric and Adolescent Patients.

Sharing clinic notes online with patients and parents may yield many potential benefits to patients and providers alike, but the unprecedented transparency and accessibility to notes afforded by patient portals has also raised a number of unique ethical and legal concerns. As the movement toward transparent notes (OpenNotes) grows, clinicians and health care organizations caring for pediatric and adolescent patients wrestle with how to document confidential and sensitive information, including issues such as reproductive health, misattributed paternity, or provider and parent disagreements. With OpenNotes now reaching >21 000 000 US patients, pediatricians continue to query best portal practices. In this Ethics Rounds, we discuss 3 illustrative cases highlighting common pediatric OpenNotes concerns and provide guidance for organizations and clinicians regarding documentation practices and patient portal policies to promote patient engagement and information transparency while upholding patient and parent confidentiality and the patient- and/or parent-provider relationship.

The Ethics of General Population Preventive Genomic Sequencing: Rights and Social Justice.

Advances in DNA sequencing technology open new possibilities for public health genomics, especially in the form of general population preventive genomic sequencing (PGS). Such screening programs would sit at the intersection of public health and preventive health care, and thereby at once invite and resist the use of clinical ethics and public health ethics frameworks. Despite their differences, these ethics frameworks traditionally share a central concern for individual rights. We examine two putative individual rights-the right not to know, and the child's right to an open future-frequently invoked in discussions of predictive genetic testing, in order to explore their potential contribution to evaluating this new practice. Ultimately, we conclude that traditional clinical and public health ethics frameworks, and these two rights in particular, should be complemented by a social justice perspective in order adequately to characterize the ethical dimensions of general population PGS programs.

Legal, Practical, and Ethical Considerations for Making Online Patient Portals Accessible for All.

Largely driven by the financial incentives of the HITECH Act's Meaningful Use program as part of federal US health care reform, access to portal Web sites has rapidly expanded, allowing many patients to view their medical record information online. Despite this expansion, there is little attention paid to the accessibility of portals for more vulnerable patient populations-especially patients with limited health literacy or limited English proficiency, and individuals with disabilities. We argue that there are potential legal mandates for improving portal accessibility (e.g., the Civil Rights and the Rehabilitation Acts), as well as ethical considerations to prevent the exacerbation of existing health and health care disparities. To address these legal, practical, and ethical considerations, we present standards and broad recommendations that could greatly improve the reach and impact of portal Web sites.

What Patients Value About Reading Visit Notes: A Qualitative Inquiry of Patient Experiences With Their Health Information.

BACKGROUND: Patients are increasingly asking for their health data. Yet, little is known about what motivates patients to engage with the electronic health record (EHR). Furthermore, quality-focused mechanisms for patients to comment about their records are lacking. OBJECTIVE: We aimed to learn more about patient experiences with reading and providing feedback on their visit notes. METHODS: We developed a patient feedback tool linked to OpenNotes as part of a pilot quality improvement initiative focused on patient engagement. Patients who had appointments with members of 2 primary care teams piloting the program between August 2014-2015 were eligible to participate. We asked patients what they liked about reading notes and about using a feedback tool and analyzed all patient reports submitted during the pilot period. Two researchers coded the qualitative responses (κ=.74). RESULTS: Patients and care partners submitted 260 reports. Among these, 98.5% (256/260) of reports indicated that the reporting tool was valuable, and 68.8% (179/260) highlighted what patients liked about reading notes and the OpenNotes patient reporting tool process. We identified 4 themes describing what patients value about note content: confirm and remember next steps, quicker access and results, positive emotions, and sharing information with care partners; and 4 themes about both patients' use of notes and the feedback tool: accuracy and correcting mistakes, partnership and engagement, bidirectional communication and enhanced education, and importance of feedback. CONCLUSIONS: Patients and care partners who read notes and submitted feedback reported greater engagement and the desire to help clinicians improve note accuracy. Aspects of what patients like about using both notes as well as a feedback tool highlight personal, relational, and safety benefits. Future efforts to engage patients through the EHR may be guided by what patients value, offering opportunities to strengthen care partnerships between patients and clinicians.

Patient portals and young people: addressing the privacy dilemma of providing access to health information.

Patient portals enable people to access their health information electronically, but concerns about confidentiality and privacy breaches, particularly for young people, may be impeding portal adoption in New Zealand. This paper considers the legal and ethical framework relating to health information privacy and informed consent in New Zealand, and proposes an approach to implementing patient portals for young people. Shared portal access (where both a young person and their parent or guardian have access to the young person's portal) may be appropriate for young children whose parents or guardians are responsible for their health care. However, as children mature and their capacity to make health care decisions increases, general practitioners will need to consider shifting to independent portal access by competent young people. The circumstances of each young person, including their best interests and rights, cultural needs and their views on information disclosure should be taken into account.

A survey of Lab Tests Online-UK users: a key resource for patients to empower and help them understand their laboratory test results.

Background Lab Tests Online-UK celebrated its 10th anniversary in 2014 and to mark the occasion the first comprehensive survey of website users was undertaken. Methods A pop-up box with a link to Survey Monkey was used to offer website users the chance to participate in the survey, which was live from 4 March 2014 to 11 April 2014. Results Six hundred and sixty-one participants started the questionnaire and 338 completed all of the demographic questions. Although the website is designed and aimed at patients and the public, a significant number of respondents were health-care professionals (47%). The majority of survey participants found the Lab Tests Online-UK website via a search engine and were visiting the site for themselves. The majority of participants found what they were looking for on the website and found the information very easy or fairly easy to understand. The patient respondents were keen to see their laboratory test results (87%), but the majority did not have access (60%) at the time of the survey. Conclusions This survey provides good evidence that the Lab Tests Online-UK website is a useful resource for patients and health-care professionals alike. It comes at a poignant time as the release of results direct to patients starts with access to their medical records. The Lab Tests Online-UK website has a key role in enabling patients to understand their lab test results, and therefore empowering them to take an interest and engage in their own healthcare.

The Ethics of Big Data: Current and Foreseeable Issues in Biomedical Contexts.

The capacity to collect and analyse data is growing exponentially. Referred to as 'Big Data', this scientific, social and technological trend has helped create destabilising amounts of information, which can challenge accepted social and ethical norms. Big Data remains a fuzzy idea, emerging across social, scientific, and business contexts sometimes seemingly related only by the gigantic size of the datasets being considered. As is often the case with the cutting edge of scientific and technological progress, understanding of the ethical implications of Big Data lags behind. In order to bridge such a gap, this article systematically and comprehensively analyses academic literature concerning the ethical implications of Big Data, providing a watershed for future ethical investigations and regulations. Particular attention is paid to biomedical Big Data due to the inherent sensitivity of medical information. By means of a meta-analysis of the literature, a thematic narrative is provided to guide ethicists, data scientists, regulators and other stakeholders through what is already known or hypothesised about the ethical risks of this emerging and innovative phenomenon. Five key areas of concern are identified: (1) informed consent, (2) privacy (including anonymisation and data protection), (3) ownership, (4) epistemology and objectivity, and (5) 'Big Data Divides' created between those who have or lack the necessary resources to analyse increasingly large datasets. Critical gaps in the treatment of these themes are identified with suggestions for future research. Six additional areas of concern are then suggested which, although related have not yet attracted extensive debate in the existing literature. It is argued that they will require much closer scrutiny in the immediate future: (6) the dangers of ignoring group-level ethical harms; (7) the importance of epistemology in assessing the ethics of Big Data; (8) the changing nature of fiduciary relationships that become increasingly data saturated; (9) the need to distinguish between 'academic' and 'commercial' Big Data practices in terms of potential harm to data subjects; (10) future problems with ownership of intellectual property generated from analysis of aggregated datasets; and (11) the difficulty of providing meaningful access rights to individual data subjects that lack necessary resources. Considered together, these eleven themes provide a thorough critical framework to guide ethical assessment and governance of emerging Big Data practices.

[Patient access to medical records. Ethical considerations on its realization in psychiatry]. / Akteneinsicht durch Patienten. Ethische Überlegungen zur Gestaltung in der Psychiatrie.

BACKGROUND: In medical ethics there is broad agreement that patients should be empowered to make autonomous decisions about their health and that objective, detailed information promotes these decisions. According to German law patients have a right of access to their own medical records. OBJECTIVES: Which advantages and disadvantages does the access to records have for doctors and patients in psychiatry? Which requirements should be met to make access reasonable for patients? MATERIAL AND METHODS: This article presents an analysis of the legal situation and the state of research, evaluation of empirical studies, discussion of features of psychiatry, its language and patients as well as their influence on access to medical records. RESULTS: Psychiatrists are sometimes concerned about patient access to medical records and some psychiatric patients feel upset or uncomfortable after having inspected their records. The misunderstanding and stigmatization of psychiatric terms, the vulnerability of psychiatric patients and the nature of psychiatric disorders, the description of which affects fundamental aspects of personality, all play a role in this. In addition, in having access to their records patients use a source of information that was originally written for other addressees. Information content and language are not adapted to their needs. Possible solutions could involve improvements in patient education and (stylistic) changes in writing records.

How bioethics principles can aid design of electronic health records to accommodate patient granular control.

Ethics should guide the design of electronic health records (EHR), and recognized principles of bioethics can play an important role. This approach was recently adopted by a team of informaticists who are designing and testing a system where patients exert granular control over who views their personal health information. While this method of building ethics in from the start of the design process has significant benefits, questions remain about how useful the application of bioethics principles can be in this process, especially when principles conflict. For instance, while the ethical principle of respect for autonomy supports a robust system of granular control, the principles of beneficence and nonmaleficence counsel restraint due to the danger of patients being harmed by restrictions on provider access to data. Conflict between principles has long been recognized by ethicists and has even motivated attacks on approaches that state and apply principles. In this paper, we show how using ethical principles can help in the design of EHRs by first explaining how ethical principles can and should be used generally, and then by discussing how attention to details in specific cases can show that the tension between principles is not as bad as it initially appeared. We conclude by suggesting ways in which the application of these (and other) principles can add value to the ongoing discussion of patient involvement in their health care. This is a new approach to linking principles to informatics design that we expect will stimulate further interest.

Return of genomic results to research participants: the floor, the ceiling, and the choices in between.

As more research studies incorporate next-generation sequencing (including whole-genome or whole-exome sequencing), investigators and institutional review boards face difficult questions regarding which genomic results to return to research participants and how. An American College of Medical Genetics and Genomics 2013 policy paper suggesting that pathogenic mutations in 56 specified genes should be returned in the clinical setting has raised the question of whether comparable recommendations should be considered in research settings. The Clinical Sequencing Exploratory Research (CSER) Consortium and the Electronic Medical Records and Genomics (eMERGE) Network are multisite research programs that aim to develop practical strategies for addressing questions concerning the return of results in genomic research. CSER and eMERGE committees have identified areas of consensus regarding the return of genomic results to research participants. In most circumstances, if results meet an actionability threshold for return and the research participant has consented to return, genomic results, along with referral for appropriate clinical follow-up, should be offered to participants. However, participants have a right to decline the receipt of genomic results, even when doing so might be viewed as a threat to the participants' health. Research investigators should be prepared to return research results and incidental findings discovered in the course of their research and meeting an actionability threshold, but they have no ethical obligation to actively search for such results. These positions are consistent with the recognition that clinical research is distinct from medical care in both its aims and its guiding moral principles.

Información escrita a pacientes: de papeles a documentos / Written information for patients: from papers to documents

Introducción. Existe una elevada variabilidad en la información documental dirigida a los pacientes, que muestra distintos contenidos, formatos y presentación. Objetivo. Conocer la percepción de seguridad de los pacientes atendidos en el Hospital Comarcal de Melilla (HCML) y valorar la calidad de los documentos mediante los criterios de adaptación del instrumento International Patient Decision Aid Standards (IPDAS). Método. Estudio descriptivo de los documentos entregados a pacientes del HCML, mediante encuesta de valoración de la percepción de seguridad, una clasificación de los documentos y análisis del grado de cumplimiento de los criterios IPDAS. Resultados. La información durante la estancia de los pacientes en el HCML, su participación en la toma de decisiones y la información sobre la medicación no superaron el valor medio de la escala de aceptación. Solo 40 documentos fueron objeto de estudio (de 131 recogidos), por ser de autoría propia y se clasificaron, siguiendo las definiciones de la RAE, en instrucciones (20), recomendaciones (14) y guías (6). De ellos, solo el 27,5% ostentó alguna imagen institucional. En el análisis de su contenido, según los criterios IPDAS, se observó un porcentaje global de cumplimiento de ítems del 24,1% en instrucciones, el 24,8% en recomendaciones y el 61,5% en guías. Conclusiones. La percepción de la seguridad de los pacientes manifestada por la encuesta y su valoración según los criterios IPDAS nos proporcionan una posibilidad de mejora importante dentro de la organización. Además, la calidad de la documentación sanitaria dirigida a pacientes puede ayudar a la toma de decisiones (AU)

Introduction. There is a high variability in the level of information intended for patients, with different content, format and presentation. Objective. To determine the perceived safety of the patients treated at the Country Hospital of Melilla (HCML) and to assess the quality of the documents using criteria adapted to the «International Patient Decision Aid Standards» (IPDAS). Method. Descriptive study of the documents given to patients by the HCML. They included questionnaires on perceived safety, classification of the documents, and the level of adherence to the IPDAS criteria. Results. The Information given to patients during their stay in the HCML, their participation in decision-making, and the information about medication, did not exceed the average on the acceptance scale. Only 40 documents were studied (of the 131 collected), on being published in-house, and were classified, following the definitions of the RAE, into instructions (20), recommendations (14) and guidelines (6). Of these, only the 27.5% showed hospital logo. In the content analysis according to the IPDAS criteria, there was an overall adherence rate of 24.1% in instructions, 24.8% in recommendations, and 61.5% in guidelines. Conclusions. The perception of patient safety expressed in the questionnaire, and its assessment according IPDAS criteria, shows there may be a significant improvement within the organization. Furthermore, the quality of patient documentation provided can help decision making (AU)

Can I access my personal genome? The current legal position in the UK.

This paper discusses the nature of genomic information, and the moral arguments in support of an individual's right to access it. It analyses the legal avenues an individual might take to access their sequence information. The authors describe the policy implications in this area and conclude that, for now, the law appears to strike an appropriate balance, but new policy will need to be developed to address this issue.